Effectiveness and Safety of an Emergency Department Code Sepsis Protocol: A Pragmatic Clinical Trial.

RATIONALE: Sepsis care delivery - including initiation of prompt, appropriate antimicrobials - remains suboptimal. OBJECTIVE: Determine direct and off-target effects of emergency department (ED) sepsis care reorganization. METHODS: This pragmatic pilot trial enrolled adult patients presenting November 2019 to February 2021 to an ED in Utah before and after implementation of a multimodal, team-based "Code Sepsis" protocol. Patients presenting to two other EDs where usual care was continued served as contemporaneous controls. The primary outcome was door-to-antimicrobial time among patients meeting Sepsis-3 criteria before ED departure. Secondary and safety outcomes included all-cause 30-day mortality, antimicrobial utilization and overtreatment, and antimicrobial-associated adverse events. Multivariable regression analyses employed difference-in-differences methods to account for trends in outcomes unrelated to the studied intervention. RESULTS: Code Sepsis protocol activation (N=307) exhibited 8.5% sensitivity and 66% positive predictive value for patients meeting sepsis criteria before ED departure. Among 10,151 patients meeting sepsis criteria during the study, adjusted difference-in-differences analysis demonstrated a 13-minute (95% CI 7-19-minute) decrease in door-to-antimicrobial time associated with Code Sepsis implementation (p<0.001). Mortality and clinical safety outcomes were unchanged, but Code Sepsis implementation was associated with increased false-positive presumptive infection diagnosis among patients meeting sepsis criteria in the ED and increased antimicrobial utilization. CONCLUSIONS: Implementation of a team-based protocol for rapid sepsis evaluation and treatment during the COVID-19 pandemic's first year was associated with decreased ED door-to-antimicrobial time but also increased antimicrobial utilization. Measurement of both patient-centered and off-target effects of sepsis care improvement interventions is essential to comprehensive assessment of their value. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov (NCT04148989) This article is open access and distributed under the terms of the Creative Commons Attribution Non-Commercial No Derivatives License 4.0 (http://creativecommons.org/licenses/by-nc-nd/4.0/).

Rapid Implementation of a Complex, Multimodal Technology Response to COVID-19 at an Integrated Community-Based Health Care System.

BACKGROUND: The rapid spread of severe acute respiratory syndrome coronavirus-2 or SARS-CoV-2 necessitated a scaled treatment response to the novel coronavirus disease 2019 (COVID-19). OBJECTIVE: This study aimed to characterize the design and rapid implementation of a complex, multimodal, technology response to COVID-19 led by the Intermountain Healthcare's (Intermountain's) Care Transformation Information Systems (CTIS) organization to build pandemic surge capacity. METHODS: Intermountain has active community-spread cases of COVID-19 that are increasing. We used the Centers for Disease Control and Prevention Pandemic Intervals Framework (the Framework) to characterize CTIS leadership's multimodal technology response to COVID-19 at Intermountain. We provide results on implementation feasibility and sustainability of health information technology (HIT) interventions as of June 30, 2020, characterize lessons learned and identify persistent barriers to sustained deployment. RESULTS: We characterize the CTIS organization's multimodal technology response to COVID-19 in five relevant areas of the Framework enabling (1) incident management, (2) surveillance, (3) laboratory testing, (4) community mitigation, and (5) medical care and countermeasures. We are seeing increased use of traditionally slow-to-adopt technologies that create additional surge capacity while sustaining patient safety and care quality. CTIS leadership recognized early that a multimodal technology intervention could enable additional surge capacity for health care delivery systems with a broad geographic and service scope. A statewide central tracking system to coordinate capacity planning and management response is needed. Order interoperability between health care systems remains a barrier to an integrated response. CONCLUSION: The rate of future pandemics is estimated to increase. The pandemic response of health care systems, like Intermountain, offers a blueprint for the leadership role that HIT organizations can play in mainstream care delivery, enabling a nimbler, virtual health care delivery system that is more responsive to current and future needs.